Perioperative Predictive Value of Physical Activity on Short- and Long-term Morbidity and Mortality
NCT07603622
Anesthesia, Surgery
Stockholm, Sweden
View Trial DetailsNCT Number: NCT07785076
This study aims to assess and improve the global outcomes following surgery. Every year approximately 313 million operations are performed, with 50 million people experiencing a complication and unfortunately 3.5 million people will die following these operations. This study will assess how outcomes vary following surgery throughout the world and explore system access, quality and efficiency.
The secondary aims of this study are to (1) assess the use of antibiotics and the impact of resistant organisms globally, (2) assess who dies after an operation and whether there are factors that were identified that could have prevented the death, (3) assess the assess and outcomes to minimally invasive and robotic surgery, (4) assess the outcomes of the Bellwether procedures (laparotomy, caesarean delivery, open fracture management) as these are conditions used to assess the functioning of a health system.
The study will take place for six week in May-June 2026 and will aim to collect data from 100,000 patients across 1000 hospitals in 100 countries to give a global perspective on the above outcome measures. The data will be analysed by hospital income group to understand how resources impact on outcomes.
By combining global data on clinical outcomes with information on hospital resources, this study hopes to provide valuable insights into how to improve surgical care across diverse settings, making recommendations that lead to better access to safe, timely and affordable care for surgical problems worldwide.
Trial opening soon.
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Observational
Background:
Surgery is a fundamental and core component of global healthcare. Without it we are unable to deliver safe maternity, trauma and cancer care. Access and treatment options vary globally. Approximately 313 million operations are performed globally every year, however high-quality outcome data is available for only a fraction of these. (1) There are estimated to be 50 million adults experiencing at least one post operative complication per year, of whom 3.5 million will die within 30 days of surgery. (1) Evidence suggests around half of complications are avoidable. (2, 3) Complications after surgery prolong inpatient admissions, increase care costs and can lead to death and disability. Global data on post-operative outcomes is lacking. We propose an International, prospective, multicentre cohort study to assess the global burden of post operative complications, its variation and sequalae.
Methodology:
This International, prospective, multicentre, global cohort study will include consecutive patients undergoing surgery within an overall six-week window between 4th May 2026 and 14th June 2026. The primary outcome will be complications measured by Clavien-Dindo grade at 30-days following surgery. Any hospital delivering surgery are eligible to participate. All patients undergoing elective or emergency operations will be included. Hospitals can have a team of up to three collaborators for each surgical speciality per week. Teams can choose to collect data for one or multiple specialities and one or multiple week periods. Hospitals can have multiple teams to allow all specialities to submit data. Data will be collected on consecutive patients from their chosen surgical specialities for one or multiple 7-day periods, with a subsequent 30-day follow-up over the six-week window. There will be no changes made to routine patient care pathways/management or follow-up as this will be an observational study. No identifiable data will be collected. There will be a mandatory site survey for all centres participating.
Appropriate registration and study approval as per local regulations is mandatory for participation. All data will be captured with REDCap - a secure online data management system.
Discussion: This study will generate data on the global variability in post operative complications for a range of common operations. This will offer insights to the global burden of disease, access to emergency and elective care, imaging and 'rescue' from complications. This data will aid in the creation of guidelines to improve care across the world and informing trial design to target areas of preventable morbidity and mortality.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 30 days
The primary aim of SurgWeek-2 is to assess the global burden and variation of postoperative complications. We will determine the frequency of postoperative complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Time frame: 30 days
We will determine the variation of postoperative infective complications across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. This will include, surgical site infection, deep organ space infection, postoperative pneumonia and anastomotic leak. We will assess patterns in antimicrobial resistances in wound swabs.
Time frame: 30 days
We will determine the variation of postoperative mortality across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. We will assess causes and patterns of postoperative mortality across countries.
Time frame: 30 days
We will determine the variation and outcomes of minimally invasive and robotic surgery across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Time frame: 30 days
We will determine the variation and outcomes of the Bellwether procedures (laparotomy, caesarean delivery and open fracture management) across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality.
Time frame: 30 days
We will determine the grade of postoperative complications according to the Clavien-Dindo classification and compare outcomes across low-, middle- and high-income countries, further stratifying by age, sex, and surgical speciality. Complication is defined as: Any deviation from the normal post-operative course that has an adverse effect on the patient and is not either a treatment failure or sequel.
Specific complications that will be assessed include:
Contact information is provided by the study sponsor or research team.
University of Birmingham
Other
Acronym: SurgWeek-2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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